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Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections

NCT05376566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-03-24

No results posted yet for this study

Summary

Aim: This study will test whether treatment of central line-associated bloodstream infections (CLABSI) with hydrochloric acid lock therapy (HALT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse of infection, or reinfection) in patients treated for cancer or hematologic diseases.

Study design: A multicentre, double-blinded, randomized controlled trial. Patient population: Patients (0-100 y) with cancer or a hematologic disorder and a CLABSI treated at Copenhagen University Hospital, Aarhus University Hospital, or Odense University Hospital, Denmark.

Randomization: Patients are equally assigned (1:1) to receive either HALT or placebo (normal saline). In addition to the study intervention, patients in both arms will receive standard systemic antibiotic therapy.

Sample size: A target population of 250 patients

Statistical Analysis Plan is uploaded in "Study Documents"

Conditions

  • Central Line-associated Bloodstream Infection (CLABSI)

Interventions

DRUG

Hydrochloric Acid (2 M)

Hydrochloric acid (2 M) in a volume corresponding to dead space (0.3-1.8 ml) will be instilled and aspirated 10 min later; the instillation is completed 3 times.

DRUG

Normal saline

Normal saline in a volume corresponding to dead space (0.3-1.8 ml) will be instilled and aspirated 10 min later; the instillation is completed 3 times.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ulrikka Nygaard, MD, ph.d. · Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376566 on ClinicalTrials.gov